Most teams document decisions. Very few control them. ParanoiaIQ™ is the decision layer your QMS is missing — ensuring every quality event is evaluated consistently, defensibly, before it becomes a regulatory event.
"Most organizations don't miss risk because they lack data. They miss it because no system forces the right decision at the right time." — Matt Collins, Founder · ParanoiaIQ™
Each engine is a structured, step-by-step decision framework for a specific regulatory problem — built from primary sources, calibrated against 189 Class I recalls, and traceable to every claim.
Based on a real Class I recall — angiographic rotating adaptor syringe, March 2026. Four serious injuries reported before recall initiation. Device class: cardiovascular. Distribution: national.
Start with the diagnostic. No budget approval risk. Immediate deliverable. If you have an inspection in 90 days, start today.
MDIC pilot across eight major device manufacturers: 65% cycle time reduction, 0.4% repeat rate, zero audit findings across 32 audits. The framework was built inside real QMS environments, not a consulting slide deck.
Every engagement leaves your team with tools they can run: trained on the method, SOP updated, decision logic documented. The next CAPA does not require another consultant.
Warning Letter remediation, consent decree compliance, Class I recall management, FDA inspection prep. The decisions you are facing have been navigated before, at companies with the same constraints yours has.
Every engagement is scoped and priced upfront. You know what you are getting, what it costs, and when it ends. No discovery phases that become projects. No scope creep disguised as thoroughness.
The ROI case: A single FDA Warning Letter costs $500K–$2M+ in remediation, lost production, and consultant fees. The Problem in Focus Sprint costs $40–75K and leaves your team with the skill, the SOP, and the precision to prevent the next one.
I built ParanoiaIQ™ because I kept seeing the same failure modes across every company I worked in: risk files that hadn't been updated since clearance, CAPAs that closed without fixing the root cause, and escalation decisions that varied by reviewer on the same event.
After 25 years inside these decisions — Warning Letter remediation, consent decree compliance, Class I recall management — I knew the pattern well enough to build a system around it.
The methodology behind ParanoiaIQ™ is backed by MDIC pilot data across eight major device manufacturers: 65% cycle time reduction · 0.4% repeat rate · zero audit findings across 32 audits.
This is not theory. It runs on data I helped generate.
Built from the same methodology powering the engines. Download free. No sales call required.
Walk your last quality event through the engine. We will show you exactly where the decision would have changed. 20 minutes. No integration required.